Associate Director, QC Microbiology

JOB SUMMARY

Responsible for overseeing microbiological programs and methods activities for

processes instruments and equipment. Ensures the effective use of material

equipment and personnel while developing products and processes at high quality

levels.

This person is responsible for the aspects of the following programs as directed by management:

• Environmental Monitoring (Air Viable Total Air Particulate Surface Viable) Clean Utility Monitoring (Water Sampling Bioburden Conductivity TOC Coliform and Nitrates)

• Compressed Gas Monitoring (Collection Air Viable Total Air Particulate Dragger Tests and specific ID tests.)

• Product Testing (Bioburden Endotoxin Host Purity or Non-Host)

• Media Release

• Laboratory Support

It is the expectation that this position is required to be onsite full time. Additionally this position should be in the laboratory at a minimum of 1 hour a day 3 time per week.

JOB RESPONSIBILITIES

• Strong understanding of monitoring programs and methods makes detailed observations and conducts troubleshooting analysis.

• Strong technical knowledge of programs. Makes detailed observations and carries out advanced data analysis.

• Execute and review routine Microbial Laboratory work.

• Utilizes technical discretion in the execution and interpretation of experiments that contribute to program goals.

• May perform testing when required.

• Strong documentation and technical writing skills.

• Familiarity with current regulations and scientific literature.

• Ensures method verifications and qualification protocols and investigations are performed appropriately. May execute testing when required.

• Maintains current state of training prior to execution of tasks.

• Assures proper labeling handling and storage of all chemical and biohazards used in the laboratory.

• Assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures and attends all required safety and health training including handling hazardous waste.

MINIMUM REQUIREMENTS

Bachelor of Science degree in a scientific discipline with a minimum of 13 15 years of technical management experience; or a Masters degree with 11 14 years or a Doctorate degree in Microbiology study and 9 12 years related experience and/or equivalent training preferred. Additionally a minimum of 5 years managerial experience.

Also requires a demonstrated track record in the following areas:

• Attainment of aggressive growth and profit objectives.

• Strong orientation for Quality and Customer Service.

• Demonstrated level of respect for individuals.

• Demonstrated contribution to science in appropriate area.

• High level of integrity and personal responsibility.

• Record of Innovation.

• Strong Collaboration and Team building skills.

Language Ability

• Ability to read analyze and interpret the most complex documents and regulations.

• Ability to respond effectively to the most sensitive inquiries or complaints.

• Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management peer group employee groups and/or customers.

Reasoning Ability

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.

• Ability to deal with nonverbal symbolism (formulas scientific equations graphs etc.) in its most difficult phases.

• Ability to deal with a variety of abstract and concrete variables.

Math Ability

• Ability to apply advanced mathematical concepts such as exponents logarithms statistical analysis and permutations. Ability to apply mathematical operations to such tasks as frequency distribution determination of test reliability and validityanalysis of variance correlation techniques sampling theory and factor analysis.

KBI Biopharma Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore all qualified applicants regardless of race color national origin religion gender gender identity sexual orientation age disability or veteran status are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma Inc. to hire me. If I am hired I understand that either KBI Biopharma Inc. or I can terminate my employment at any time and for any reason with or without cause and without prior notice. I understand that no representative of KBI Biopharma Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.